Myopia Master

GUDID 04049584029942

The Myopia Master combines different measuring functions in one unit.The Auto-Refractometer calculates the ametropia in D, the Keratometer determines the curvature of the cornea. The axial length of the eye is measured and displayed by interferometry.

OCULUS Optikgeräte Gesellschaft mit beschränkter Haftung

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• Primary Device ID: 04049584029942
• NIH Device Record Key: c30c5e7c-33bb-47d3-80db-a8874ef56df2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Myopia Master
• Version Model Number: 68120
• Company DUNS: 317138956
• Company Name: OCULUS Optikgeräte Gesellschaft mit beschränkter Haftung
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04049584029942 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202989

FDA Product Code

• MXK: Device, Analysis, Anterior Segment

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-11-11
• Device Publish Date: 2021-11-03

On-Brand Devices [Myopia Master]

• 04049584029959: The Myopia Master combines different measuring functions in one unit.The Auto-Refractometer calc
• 04049584029942: The Myopia Master combines different measuring functions in one unit.The Auto-Refractometer calc